Gazyva: adverse event reports filed with FDA

5,294

reports as suspect product

0% of all reports · about 424 a year

512

reports, 12 months to June 2026

1,049 in the 12 months before

65.9%

marked serious by the reporter

77% across the class

12.3%

record death among outcomes, as reported

652 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Gazyva reports recording the termmedian drug in cd20-directed cytolytic antibody

1. Off label useused for a purpose or in a way not on the label12.8%675
2. Infusion related reactiona reaction during or soon after an infusion7.2%383
3. No adverse eventno adverse event was reported6.5%343
4. Pyrexiafever6.1%325
5. Chillschills or shivering5.9%311
6. Covid-19COVID-19 infection5.7%303
7. Dyspnoeashortness of breath4.7%249
8. Deaththe patient died; cause not stated by this term4.6%245
9. Nauseafeeling sick4.5%240
10. Myelosuppression4.4%232
11. Disease progressionthe disease advanced4.2%224
12. Neutropenialow neutrophils, a type of white blood cell4.2%220
13. Platelet count decreasedlow platelet count3.9%206
14. Pneumonialung infection3%157
15. Fatiguetiredness2.9%156
16. Hypotensionlow blood pressure2.9%151
17. Thrombocytopenialow platelets2.8%147
18. Rashskin rash2.6%139
19. Vomitingbeing sick2.6%138
20. White blood cell count decreasedlow white cell count2.5%133
21. Chest discomfortchest discomfort2.4%128
22. Diarrhoealoose or frequent stools2.1%109
23. Astheniaweakness or lack of energy2%107
24. Neutrophil count decreased2%106
25. Drug ineffectivethe medicine did not work as expected1.8%96
26. Flushingsudden reddening or warmth of the skin1.7%91
27. Hypertensionhigh blood pressure1.7%90
28. Coughcough1.6%87
29. Intentional product use issuedeliberate use not as intended1.6%87
30. Blood pressure decreaseda low blood pressure reading1.6%84

Top 30 of 595 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 12 drugs in the cd20-directed cytolytic antibody class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 316,120 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 44.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,294 reports.

Drugs most often listed in the same reports

Other products listed in reports where Gazyva is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the cd20-directed cytolytic antibody class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Gazyva as a suspect or interacting product; reports listing it only as a concomitant medication (706) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.